Drug Safety: FDA will monitor Medicare claims data for drug problems

June 13, 2008

Here's one more reason why the feds are pushing for a nationwide health information network--the ability to scour millions of electronic records and catch unexpected drug side effects as soon as possible.

Here’s one more reason why the feds are pushing for a nationwide health information network-the ability to scour millions of electronic recordsand catch unexpected drug side effects as soon as possible.

The FDA plans to do just that with its so-called Sentinel Initiative. Last month , the agency announced that its electronic surveillance program will encompass claims data for 25 million patients in the Medicare Part D prescription program, along with related inpatient and outpatient claims data. New regulations from the Centers for Medicare and Medicaid Services make Part D claims-stripped of information that would identify individual patients-available to government and academic researchers.

The ultimate goal is incorporating electronic health records from other federal agencies such as the Veterans Health Administration, EHRs maintained by private healthcare providers, and claims data from private payers. The FDA stresses that participation by private entities in the Sentinel Initiative is voluntary. One insurer likely to come aboard is WellPoint, which earlier this year announced the launch of an electronic surveillance program based on its own claims data.

The Sentinel Initiative will monitor not only medications, but also other medical products that the FDA approves for marketing. In the past, the FDA has relied on the healthcare industry to voluntarily report problems with new medical products. Electronic surveillance is a more aggressive approach toward quality control.

“With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people,” said FDA Commissioner Andrew C. von Eschenbach in an FDA press release. “The era of ‘wait and see’ is going to become the era of ‘tell me rightnow.’”